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Bavencio 20 mg/mL concentrate for solution for infusion

Active Ingredient:
avelumab
Company:  
Merck See contact details
ATC code: 
L01FF04
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) Risk Materials
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Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

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Bavencio 20 mg/ml concentrate for solution for infusion (avelumab) – Patient Alert Card

{healthcare_pro_orange} For Healthcare Professionals

The change is triggered by the approval of the Type II safety variation in UK PLGB 11648/0262 – 0044 and introduction of the new version of the RMP v 10.0 for Bavencio 20 mg/ml concentrate for solution for infusion.

Proposed changes are:

The risk of immune-mediated gastritis was added under the important identified risk of ‘Immune-mediated adverse reactions’ in all the relevant modules of RMP.

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Merck
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Address
Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK
Medical Information Direct Line
+44 (0)208 818 7373
Telephone
+44 (0)208 818 7200
Fax
+44 (0)208 818 7267
Medical Information Fax
+44 (0)208 818 7274
Medical Information e-mail
[email protected]